Healthy
Conditions
Brief summary
The objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.
Detailed description
In this open-label, three-period crossover study, 12 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have three lidocaine topical systems applied to their back for 12 hours with 7-day washout between treatments. In each treatment period, the subject will either exercise (Treatment A), apply a heating pad (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 48 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.
Interventions
Sponsors
Scilex Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Must be healthy based on by medical history, laboratory work, and physical exam * Be at least 18 years of age * If childbearing potential, use of acceptable form of birth control * In the case of females of childbearing potential, have a negative serum pregnancy test Key
Exclusion criteria
* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation * Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin * Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin) * History of addiction, abuse, and misuse of any drug * Use of nicotine-containing products within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of lidocaine | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose | Peak plasma concentration of lidocaine after application of 3 patches for 12 hours |
| Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose | Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma |
| Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose | Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma |
| Cumulative Adhesion Score | 0, 0.5, 3, 6, 9, 12 hours post-dose | Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Response Score | 12.5 and 14 hours post-dose | Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site. |
Outcome results
None listed